| Methods |
STUDY DESIGN: Parallel group, general practice setting in UK‐ 3516 GPs. 16 weeks treatment.
RANDOMISATION: Yes, computer generated random code, blocks of 6.
BLINDING: double blind, double dummy, matching devices. Monitoring staff unblinded.
WITHDRAWALS/DROP OUTS: 6481, causes fully described.
COMPLIANCE: Not assessed/ reported.
CONFOUNDERS: Groups well balanced by characteristics. Possibility of confounding by severity of asthma.
QUALITY: Jadad 5. Cochrane A |
| Participants |
N = 25180 randomised (TT) Adults, M = 10479 F = 14701 Mean age not reported, range 18 to > 60
BASELINE SEVERITY: mild 17%, moderate 65%, severe 17% as categorised at randomisation by GP.
INCLUSION : Clinical diagnosis of asthma requiring regular SABA
EXCLUSION: Beta blocker use, serious uncontrolled diseases , pregnancy. |
| Interventions |
LONG ACTING BETA AGONIST Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: Placebo BD
DEVICE: MDI
TREATMENT PERIOD: 16 weeks
RESCUE: Patients usual rescue agent PRN
CO‐INTERVENTIONS: ICS 69%, OS 4.7%, Theophyllines, cromones, ipratropium‐ stable doses |
| Outcomes |
OUTCOMES: Deaths related to asthma, Admission to hospital‐ respiratory or asthma related. other serious adverse events related to asthma, withdrawals for respiratory or related to asthma. |
| Notes |
No definition of asthma exacerbation. Serious adverse event related to asthma= event requiring hospital admission, prolonging stay, life threatening or severely disabling. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
